BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXGEN PROLONG CR ARTICULAR SURFACE

    MDR report key: 2100523 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01174
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVAL SUMMARY: IMPLANT COMPATIBILITY WAS CONFIRMED. SURGICAL NOTES WERE PROVIDED AND REVIEWED. NOTHING EXCEPTIONAL WAS NOTED. X-RAYS WERE NOT PROVIDED FOR REVIEW. AS SUCH, THE IMPLANT CONSTRUCT CANNOT BE ANALYZED RADIOGRAPHICALLY. BASED ON THE AVAILABLE INFORMATION AN EXACT CAUSE FOR THE REPORTED CONDITION CANNOT BE DETERMINED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION REGARDING THE CASE BE RECEIVED SUBSEQUENT TO COMPLAINT CLOSURE, THE COMPLAINT WILL BE RE-OPENED AND RE-PROCESSED AT THAT TIME. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN WHEN WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN PROLONG CR ARTICULAR SURFACE JWH ZIMMER INC 60171244

    Patients

    Seq Age Sex Outcome Treatment
    1 Other NEXGEN CRUCIATE RETAINING FEMORAL COMPONENT:| CATALOG #00597001601, LOT #60183490| STEMMED TIBIAL COMPONENT: CATALOG #00598004701| NEXGEN ALL POLY PATELLA: CATALOG #00597206532| LOT #60169860| LOT #60161936